Vanderbilt-Ingram Cancer Center

Clinical Trial COGACNS0927

Title

A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

Principal Investigator(s)

Adam Esbenshade

Details

• Protocol No. COGACNS0927
• Open Date: 03/22/2012
• Staging: Phase I/II
• Age Group: Both Child and Adult
• Scope: National
• Objective: 1 - To estimate the maximum tolerated dose (MTD) or recommend a Phase 2 dose of vorinostat given concurrently with radiation in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). 2 - To define and describe the toxicities of vorinostat given concurrently with radiation in children with newly diagnosed DIPG. 3 - To determine, in the context of this phase I/II trial, the anti-tumor activity of combining vorinostat with radiation, followed by maintenance vorinostat for twelve courses, in children with newly diagnosed DIPG, as measured by 12-month event-free survival (EFS) and overall survival (OS). 4 - To determine the toxicities of vorinostat for 12 additional courses after completion of vorinostat and radiation.
• Disease Sites: Pediatric Solid Tumors
• Therapies: Chemotherapy - cytotoxic; Radiotherapy
• Drugs: Vorinostat (ZOLINZA)
• Participating Institutions: Vanderbilt University
• Secondary Protocol No: ACNS0927

Description

Eligibility

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